In April 2025 the US Food and Drug Administration announced a plan to phase out animal testing requirements for monoclonal antibodies and other drugs in favor of new approach methods.

Is it true that in April 2025 the US Food and Drug Administration announced a plan to phase out animal testing requirements for monoclonal antibodies and other drugs in favor of new approach methods?

Yes. Three peer-reviewed sources state that in April 2025 the FDA announced a roadmap or plan to phase out animal testing requirements in drug development, including monoclonal antibodies, in favor of New Approach Methodologies such as organoids, organs-on-chips and AI models. A fourth source confirms a 2025 US agency shift toward human-relevant methods without the April date or antibody detail.

Verdict: SUPPORTED · 4 sources for, 0 against · Last checked 2 Oct 2026

The private library was unavailable for some searches in this check. Missing library results are not evidence against the claim.

The FDA’s Plan to Phase Out Animal Testing - PMC Lock. (n.d.). pmc.ncbi.nlm.nih.gov. https://doi.org/10.1016/j.tibtech.2025.12.011

Min, H., Lexuan, D., Yi, G., Ziqi, X., Zihao, S., & Ruiyang, T. (2025). Prospects for 3D Bioprinting Research and Transdisciplinary Application to Preclinical Animal Models. slarc.org.cn. https://www.slarc.org.cn/dwyx/article/2025/1674-5817/1674-5817-2025-45-3-318.shtml

Lei, Y., Tuan, R. S., & Li, Z. A. (2026). FDA roadmap to reducing animal testing: a regulatory and scientific paradigm shift in nonclinical safety assessment. doi.org. https://doi.org/10.1186/s13287-026-05090-6

Z, N. (2025). Path dependency and the rescuing of the biomedical research enterprise.. doi.org. https://doi.org/10.3389/fmedt.2025.1683835